The Recall Desk

FDA (Devices) recall action 67813

Stryker Communications recalled 5 products on 2014-07-23

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2014-07-23
Critical
0
Units
4,765

Why these products were recalled

During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2014-07-23

    Stryker Communications Recalls SHAPE Arm Monitor Mounts

    Stryker Communications is recalling SHAPE Arm monitor mounts because the mount may detach if a lock washer and screw are missing.

    Product
    SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682400256 and
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-07-23

    Stryker SHAPE Arm Dual SH2 Recalled for Potential Monitor Detachment

    Stryker Communications is recalling SHAPE Arm Dual SH2 brackets because the monitor mount may detach if specific hardware is missing.

    Product
    SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm par
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-07-23

    Stryker SHAPE Arm Recall for Potential Monitor Mount Detachment

    Stryker Communications is recalling 953 SHAPE Arm components because the monitor mount may detach if a lock washer and screw are missing.

    Product
    SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-07-23

    Stryker Communications Recalls SHAPE Arm Brackets for Potential Monitor Detachment

    Stryker Communications is recalling 953 SHAPE Arm brackets because the monitor mount may detach if a lock washer and screw are missing.

    Product
    BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the Ar
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2014-07-23

    Stryker Communications Recalls SHAPE Arm Brackets for Boom Systems

    Stryker Communications is recalling 953 SHAPE Arm brackets used in operating rooms because the monitor mount may detach if specific hardware is missing.

    Product
    BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm p
    Category
    Distribution
    1 state